A Jemal

AA Forastiere

B Vikram

C Linder

DR Spigel

DV Catenacci

E Crozier

EE Cohen

F Linkov

F Qian

G Cortesina

G Maulik

George Blumenschein

H Xu

Harold N. Keer

Howard Kallender

JA Engelman

JB Vermorken

John Sarantopoulos

JP Eder

JSW Stewart

L Kim

L Liu

LF Chen

LM Knowles

LV Sequist

MG Fury

MM Oken

P Salven

P Therasse

R Simon

S Marur

Stewart McCallum

T Yau

Tanguy Seiwert

TY Seiwert

ZJ Shang

Summary
          Background Foretinib is a small-molecule, oral multikinase inhibitor primarily targeting the mesenchymal epithelial transition (MET) factor receptor, and the vascular endothelial growth factor receptor 2. We conducted a phase II study to evaluate the single-agent activity and tolerability of foretinib in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN). Methods An open-label, single-arm, multicenter trial employing a Simon 2-stage design was conducted with a total of 41 patients planned for the study. One or more responses in the first 14 patients were required in order to progress to the second stage. Foretinib was administered as 240 mg orally for 5 consecutive days of a 14-day treatment cycle (5/9 schedule) to patients with recurrent and/or metastatic SCCHN. Results Fourteen patients were enrolled. The study did not meet criteria for continuing to the second stage. A maximum of 30 cycles were administered (median = 4.0). Fifty percent of patients (7/14) showed stable disease (SD), 43 % of patients (6/14) experienced tumor shrinkage and two patients had prolonged disease stabilization for ≥13 months. The most common adverse events were fatigue, constipation and hypertension, which were manageable with additional medication or adjustments to the dosing schedule. Conclusion Foretinib 240 mg on a 5/9 schedule was generally well tolerated. SD was the best-observed outcome, with minor tumor shrinkage detected in nearly half of all patients. The efficacy results, prolonged disease stabilization and tolerable side-effect profile, support further investigation, possibly in combination with other targeted agents or cytotoxic chemotherapy for SCCHN.</jats:p

Crossref

Investigational New Drugs

Phase II trial of single-agent foretinib (GSK1363089) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck

https://link.springer.com/content/pdf/10.1007%2Fs10637-012-9861-3.pdf

Phase II trial of single-agent foretinib (GSK1363089) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck

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